# K032818: Inogen One Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Inogen, Inc.
- Decided: May 13, 2004 after 246 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020324 (2002). 1 ancestor in all.
8 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020324: Lifestyle Oxygen Concentrator, Airsep Corp. (2002) Summary page 1.

## Most influential descendants
- K071928: The Invacare Flyer, Model Ipc 100 (2007), 3 descendants of its own
- K160630: Invacare Platinum Mobile Oxygen Concentrator (2016), 1 descendant of its own
- K121260: Trooper Oxygen Concentrator (2012), 1 descendant of its own
- K211056: Oxus Sieve Beds (2023), 0 descendants of its own
- K200496: Aer X (2020), 0 descendants of its own

## Recalls of this device
- Aug 1, 2005 · Not classified · Z-1368-05: Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.

## Indications for use
The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.

Source page: https://510kreport.com/device/K032818
Methodology: https://510kreport.com/methodology